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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00398546 | Other Identifier | Johns Hopkins IRB |
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| Name | Class |
|---|---|
| Oncovir, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the safety of a cancer peptide vaccine to prevent or delay acquired resistance in advanced ALK+ lung cancer patients currently on ALK targeted therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Advanced ALK+ NSCLC | Experimental | All patients will receive the intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peptide vaccine | Biological | Peptide vaccine |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-related adverse events | The safety of administering the ALK peptide vaccine will be assessed by the occurrence of the following adverse events:
| Up to 2 years |
| Vaccine-specific immune response | Vaccine-specific response will be evaluated by the fold change in interferon-producing mutant-ALK-specific CD8 and CD4 T cells in the peripheral blood. | Up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Known additional malignancy that is progressing or has required active treatment within the past 3 years. Adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors treated with potentially curative therapy are allowed.
Cytotoxic chemotherapy within 14 days of first dose of study vaccine or concurrent with study vaccine
Anti-neoplastic immunotherapy within 28 days of first dose of study vaccine or concurrent with study vaccine
Systemic immune suppression:
Symptomatic central nervous system (CNS) metastasis. Asymptomatic CNS disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment is also not permitted
Current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent Lam, MD | Contact | 410-955-8964 | ThoracicCancerTrials@jhmi.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vincent Lam, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Recruiting | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000096202 | Protein Subunit Vaccines |
| ID | Term |
|---|---|
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D045424 |
| Complex Mixtures |